Fluorescein Angiography ImagingNCT04201340
Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study
An observational study of Fluorescein Angiography Imaging, run by Topcon Corporation at 1 site in United States.
Trial summary
Comparisons for vascular structure visualization in the retina and choroid. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fluorescein Angiography Imaging
- What is being tested?
- DRI OCT Triton with SS-OCT Angio software, Cirrus HD-OCT 5000 and TRC-50DX
- Type of treatment
- Medical device
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 20 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with normal eyes or retinal pathology
Who may be able to join
None listed.
Who cannot join
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
- Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease
- Narrow angle
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine or chloroquine
Show all 19Show fewer
- Subjects where the study eye was treated after screening and before imaging
- RETINAL GROUP Inclusion Criteria
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
- BCVA 20/400 or better in the study eye
- Diagnosis of some type of retinal pathology likely to present in the vasculature in at least one eye as determined by the investigator, may include, but is not limited to: Diabetic retinopathy, Retinal Vein occlusions, Exudative AMD or Macular telangiectasia with expected presentation in the vasculature of, including but not limited to, microaneurysms, capillary dropout and/or choroidal neovascularization.
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
- Subjects with known allergy to fluorescein or if ICGA is clinically indicated, indocyanine green dyes, shellfish, iodine, or subjects having liver disease, or end-stage renal disease
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine or chloroquine
- Subjects where the study eye was treated after screening and before imaging
Trial locations and contacts
1 site in 1 country.
About this study
Comparisons for vascular structure visualization in the retina and choroid.
- Conditions
- Fluorescein Angiography Imaging
- Being tested
- DRI OCT Triton with SS-OCT Angio software, Cirrus HD-OCT 5000, TRC-50DX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRI OCT Triton with SS-OCT Angio softwareDevice
The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000Device
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DXDevice
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Subjects Presenting with Normal Eyes | Subjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX Receives: Device: DRI OCT Triton with SS-OCT Angio software; Device: Cirrus HD-OCT 5000; Device: TRC-50DX | |
| Subjects with retinal pathology present in the vasculature | Subjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX Receives: Device: DRI OCT Triton with SS-OCT Angio software; Device: Cirrus HD-OCT 5000; Device: TRC-50DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference
Comparison of OCT devices to TRC-50DX
Measured: Day 1
Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference
Comparison of OCT devices to TRC-50DX
Measured: Day 1
Agreement of pathology identification between the two OCT-A devices
Compare the pathology identifications between the OCT-A devices
Measured: Day 1
Secondary outcomes (1)
OCT-A image quality score (poor, average and good)
Image quality score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start11 Dec 2019
- Primary completion28 Jul 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorescein Angiography ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayra Tafreshi, Study director, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201340
- Sponsor's protocol ID
- Triton OCT-A
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study
- ClinicalTrials.gov ID
- NCT04201340
- Acronym / sponsor ID
- Triton OCT-A
- Conditions
- Fluorescein Angiography Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparisons for vascular structure visualization in the retina and choroid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Presenting with Normal Eyes | – | Device: DRI OCT Triton with SS-OCT Angio software, Device: Cirrus HD-OCT 5000, Device: TRC-50DXSubjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
| Subjects with retinal pathology present in the vasculature | – | Device: DRI OCT Triton with SS-OCT Angio software, Device: Cirrus HD-OCT 5000, Device: TRC-50DXSubjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with normal eyes or retinal pathology
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
- Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease
- Narrow angle
- History of leukemia, dementia or multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRI OCT Triton with SS-OCT Angio softwareThe Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes | Device | Subjects Presenting with Normal Eyes, Subjects with retinal pathology present in the vasculature |
| Cirrus HD-OCT 5000The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes | Device | Subjects Presenting with Normal Eyes, Subjects with retinal pathology present in the vasculature |
| TRC-50DXThe TRC-50DX retinal camera images the fundus used for diagnostic purposes | Device | Subjects Presenting with Normal Eyes, Subjects with retinal pathology present in the vasculature |
Primary outcome
Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference
Time frame: Day 1
Comparison of OCT devices to TRC-50DX
Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference
Time frame: Day 1
Comparison of OCT devices to TRC-50DX
Agreement of pathology identification between the two OCT-A devices
Time frame: Day 1
Compare the pathology identifications between the OCT-A devices
1 secondary outcome
OCT-A image quality score (poor, average and good)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayra Tafreshi study director
Topcon Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluorescein Angiography Imaging, run by Topcon Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.